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Academics work together to uncover mass scientific fraud

Three University of Auckland academics worked tirelessly for over five years to uncover one of the biggest scientific frauds in history.

Associate Professors Mark Bolland and Andrew Grey together with biostatistician Greg Gamble of the School of Medicine in the Faculty of Medical and Health Sciences, spent thousands of hours combing over the papers of 33 research trials, more than 50 animal trials, and many other papers by a research group from Japan.

They, alongside Professor Alison Avenell, a clinical nutritionist at the University of Aberdeen, had discovered that dozens of clinical trials covering topics such as bone fractures and Alzheimer’s published in international journals included fabricated data.

Dr Bolland says the issue of research fraud and faking results is extremely serious as it leads to people being treated based on evidence that is false. It also influences other scientists, doctors and academics on what avenues to follow for their own research.

“Researchers should provide legitimate, accurate and precise outcomes of their research,” Dr Bolland says.

“Inaccurate or fabricated findings distort the evidence which guidelines for treating people are based on, by exaggerating possible benefits from treatments, or even worse, promoting treatments that at best are ineffective, or at worst are actually harmful. The consequences of inaccurate research can persist for many years.”

Dr Bolland was first alerted to the research of the Japanese group by Dr Avenell in 2012. They have never met in person but along with Dr Grey and Greg Gamble they started investigating.

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They looked up the papers and were stunned by the number of trials published within a very short space of time. These trials had large cohorts, low number of dropouts, and reported very large effects of almost any treatment tested.

Dr Bolland also found the baseline characteristics for things like age, weight, and sex in the trials by this research group were so incredibly similar there was just one plausible explanation: the data had been fabricated for both groups, making them far more similar than they would ever be in real life.

This fraud is one of the biggest in scientific history, with more than 45 retracted papers to date, and likely many more to follow.

Dr Avenell’s suspicions were first raised in 2006 when she was reviewing research into whether vitamin D reduces the risk of bone fractures. In two papers from this group, she stumbled on a weird coincidence. They described different trials, one in stroke victims, the other in Parkinson’s disease patients, but the control and study groups in both studies had the exact same mean body mass index. The journals were alerted about this and a number of problems with other papers at the time, but no action followed.

Other anomalies in the research by this group included suspiciously large research cohorts, including one study on frail elderly women with Alzheimer’s disease in which the researchers claimed to have recruited 500 patients in just two months from a small provincial hospital, and one researcher personally did follow-up assessments on all of them every four weeks for 18 months. This took place alongside numerous other trials which also rapidly recruited large numbers of patients and followed them up intensively.

As a result of this group’s research, meta-analyses that included their trials came to the wrong conclusion and professional societies based medical guidelines on their fraudulent papers. Other researchers followed up the research by carrying out new trials that enrolled thousands of real patients.

In May 2013, Dr Bolland’s team submitted their findings to The Journal of the American Medical Association (JAMA), which had published one of the affected papers. But after two years of waiting the journal told the four researchers it would not publish their findings. Two other journals also rejected their paper. In December 2016, the journal Neurology published the group’s findings. As a consequence of this work, 21 of the 33 trials reviewed in the paper have been retracted to date.

Now Dr Bolland and the team are working on the ripples the studies has caused, focusing, for the time being, on a dozen papers published in the journals with the highest impact factors. Together, these studies reported results for 3182 participants. They have been referenced more than 1000 times, and 23 systematic reviews or meta-analyses have included one or more of the 12 trials.

“The influence of fake trials like this doesn’t disappear overnight. Sadly they continue to influence people for decades to come, so any work that stems the tide of misinformation is extremely important,” Dr Bolland says.

Ends

Notes for editor:
Tide of Lies, Science, 17 Aug 2018: Vol. 361, Issue 6403, pp. 636-641.
• Systematic review and statistical analysis of the integrity of 33 randomized controlled trials. Published in Neurology in November 2016.

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